Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075690
Company: ACTAVIS MID ATLANTIC

• Other Important Information from FDA

Products on ANDA 075690

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
FLUOXETINE HYDROCHLORIDE	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE/5ML	SOLUTION;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 075690

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/31/2002	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75690TA.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/18/2023	SUPPL-9	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
09/20/2021	SUPPL-8	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
12/17/2002	SUPPL-1	Manufacturing (CMC)-Packaging		Label is not available on this site.